【発明の詳細な説明】（産業上の利用分野）本発明は管状器官の内腔の内径を確保するための拡張保
持具およびこの拡張保持具を導入又は回収するためのカ
テーテルに関する。DETAILED DESCRIPTION OF THE INVENTION (Field of Industrial Application) The present invention relates to an expansion holder for securing the inner diameter of a lumen of a tubular organ, and a catheter for introducing or retrieving the expansion holder.
（従来の技術）例えば冠動脈の狭搾部を血管拡張カテーテルで′拡張し
た後、その部分の再狭搾を防止する場合など、一般に管
状器官の内腔の内径を確保することを目的として拡張保
持具（以下、ステントとも呼ぶ）が用いられている。(Prior art) For example, when a narrowed portion of a coronary artery is dilated with a vasodilator catheter and then the narrowed portion is dilated, the expansion and maintenance is generally performed to maintain the inner diameter of the lumen of a tubular organ, such as when preventing the narrowed portion of the coronary artery from being re-narrowed. (hereinafter also referred to as a stent) is used.
、従来、このような目的に用いられるステントとしてス
テンレスワイヤを網状に織ったもの（Ｓｕｒｇｅｒｙ、
１９８６年、９９巻２号、第１９９−２０５頁）、あ
るいは一方向性形状記憶合金製のもの（特公昭６ｌ−６
６５５）、が考案されている。このステンレス製ステン
トを用いて例えば血管拡張の確保を行う場合、血管の所
定位置にステントを血管拡張カテーテルを介して導入し
、ついでカテーテル先端部に設けられたバルーンを拡張
してステントを血管径軒拡げることができる。また、一
方向性形状記憶合金製ステントの場合は同じく血管の所
定個所に導入後温水等で加熱してステントの拡張がおこ
なわれる。Conventionally, stents made of stainless wire woven into a net-like structure have been used for such purposes (Surgery,
1986, Vol. 99, No. 2, pp. 199-205), or one made of unidirectional shape memory alloy (Special Publication Sho 6l-6
655) has been devised. When using this stainless steel stent, for example, to ensure blood vessel expansion, the stent is introduced into a predetermined position in the blood vessel via a blood vessel dilation catheter, and then a balloon provided at the tip of the catheter is expanded to extend the stent over the blood vessel diameter. Can be expanded. In the case of a unidirectional shape memory alloy stent, the stent is similarly expanded by heating it with hot water or the like after being introduced into a predetermined location in a blood vessel.
（発明が解決しようとする問題点）このようにして、いったん拡張されたステントは外力を
与えない限り、その形状を変化させることができず、留
置後、術部が回復しても再び取り出すことができない。(Problem to be solved by the invention) In this way, once expanded, the stent cannot change its shape unless an external force is applied to it, and even after the stent has been indwelled and the surgical site has recovered, it cannot be taken out again. I can't.
そのため生体への適合性が非常に問題となっている。そ
のほか、このような従来のステントは留置位置が誤って
いることが拡張後発見されたとしても、いったん拡張さ
れた後は、その留置位置の変更は極めて困難であった。Therefore, compatibility with living organisms has become a serious issue. In addition, even if it is discovered after expansion that such a conventional stent is placed in the wrong position, it is extremely difficult to change the placement position once the stent has been expanded.
本発明は上記事情に鑑み、管状器官内でいったん拡張さ
せた場合でも再び自由に元の形状に縮小させることがで
き、したがって留置位置からの回収が可能であるととも
に、拡張後における留置位置の変更も自由にできる管状
器官用ステントおよびこのステントを操作するためのカ
テーテルを提供することを目的とする。In view of the above-mentioned circumstances, the present invention has been developed so that even if the tubular organ is once expanded, it can be freely contracted back to its original shape, and therefore it can be recovered from the indwelling position, and the indwelling position can be changed after expansion. An object of the present invention is to provide a stent for a tubular organ that can be used freely, and a catheter for operating the stent.
（問題点を解決するための手段）本発明は上記問題点を解決するため、ステントとして二
方向性形状記憶合金を用いるという手段を講じるととも
に、このステントを、側孔を設けたカテーテル先端に取
着させ、この側孔を介して冷却水をステントに適宜接触
させステントの縮小。(Means for Solving the Problems) In order to solve the above problems, the present invention takes a measure of using a bidirectional shape memory alloy as a stent, and also attaches this stent to the tip of a catheter provided with a side hole. The stent is shrunk by bringing cooling water into contact with the stent through the side holes.
拡張を自由におこなうことを可能としたものである。This allows for free expansion.
すなわち、この発明は上記問題点を解決する手段として
、温度変化にともなって径方向に拡張又は収縮し得る二
方向性形状記憶合金のらせん状または実質的に筒状の成
形体からなることを特徴とする管状器官用ステントを提
供するものである。That is, as a means for solving the above-mentioned problems, the present invention is characterized by comprising a helical or substantially cylindrical molded body of a bidirectional shape memory alloy that can expand or contract in the radial direction with temperature changes. The present invention provides a stent for tubular organs.
なお、この二方向性形状記憶合金筒状体は体温又は体温
近傍で拡張状態を保ち、これより実質的に低い温度では
縮少状態を保つようなものであることが好ましい。It is preferable that the bidirectional shape memory alloy cylindrical body maintains an expanded state at or near body temperature, and maintains a contracted state at temperatures substantially lower than this.
さらに、この発明は基端又は両側が開口し、その先端近
傍の周面にこの開口部と連通ずる少なくとも１個の側孔
を穿設してなるカテーテルチューブと、このカテーテル
チューブ後端に連通ずるようにして設けられたハブ部と
、温度変化にともなって径方向に拡張又は収縮し得る二
方向性形状記憶合金筒状体からなり、上記カテーテルチ
ューブの先端の側孔穿設部の少なくとも一部を覆うよう
にして装着された管状器官内腔の内径確保用器具とを具
備してなることを特徴とする管状器官用ステントを備え
たカテーテルを提供するものである。Further, the present invention provides a catheter tube having an opening at the proximal end or both sides thereof and having at least one side hole bored in the circumferential surface near the distal end thereof communicating with the opening, and a catheter tube having an opening at the proximal end or both sides thereof, and a catheter tube having at least one side hole in communication with the opening. At least a portion of the side hole drilling portion at the distal end of the catheter tube, comprising a hub portion provided in this manner and a bidirectional shape memory alloy cylindrical body that can expand or contract in the radial direction with temperature changes; The present invention provides a catheter equipped with a stent for a tubular organ, characterized in that it is equipped with a device for securing the inner diameter of the lumen of the tubular organ, which is attached to cover the stent.
なお、上記カテーテルのハブ部は２つのポートを具備し
た分岐ハブであって、その一方のポートに逆止弁を設け
るようにしてもよい。The hub portion of the catheter may be a branch hub having two ports, one of which may be provided with a check valve.
なお、本発明において形状記憶合金とは変態温度を有し
、この温度以上になるとあらかじめ記憶させた形状に変
化するものをいい、一方向性形状記憶合金とは変態温度
以下のときは自由に変形でき、変態温度以上となり形状
変化するとその後変態温度以下になっても記憶した形状
を維持するものをいい、二方向性形状記憶合金とは変態
温度以下での形状も記憶しており、変態温度を境に２つ
の形状を可逆的に発現するものを言う。In the present invention, a shape memory alloy refers to an alloy that has a transformation temperature and changes to a pre-memorized shape when the temperature exceeds this temperature, and a unidirectional shape memory alloy refers to an alloy that deforms freely when the temperature is below the transformation temperature. Bidirectional shape memory alloys are alloys that retain their memorized shape even when the temperature exceeds the transformation temperature and change their shape even when the temperature drops below the transformation temperature. It refers to something that reversibly develops two shapes at the border.
（実施例）以下、この発明を図示の実施例を参照して説明する。(Example)The present invention will be described below with reference to illustrated embodiments.
第１図（ａ）、（ｂ）は本発明の一実施例に係わる管状
器官用ステント１０を示すものであって、偏平な二方向
性形状記憶合金線条体（例えばＮｉ−Ｔｉ系、Ｃｕ−Ａ
ｌーＮｉ系、Ｃｕ−Ｚｎ−Ａ）系合金からなる）をらせ
ん状に成形したものからなる。このステント１０は体温
又は体温に近傍する温度（例えば３５〜３７℃）では第
１図（ｂ）の如く径方向に拡張した形状を保ち、それよ
り実質的に低い温度（例えば１５〜２０°Ｃ）では第１
図（ａ）に示す如く径方向に収縮した形状を保つ。例え
ば、肉厚０．０４ｍｍ、幅１ ｍｍのＮｉ−Ｔｉ系二方
向性形状記憶合金（Ｎｉを約５１原子量％含む）をらせ
ん状に成形したステントにおいては体温で約２ ｍｍの
内径のものが温度１５℃以下で内径約１．４ｍｍに収縮
させることができた。FIGS. 1(a) and 1(b) show a stent 10 for tubular organs according to an embodiment of the present invention. -A
It is made of a l-Ni type, Cu-Zn-A type alloy) formed into a spiral shape. The stent 10 maintains its radially expanded shape as shown in FIG. ), then the first
It maintains a radially contracted shape as shown in Figure (a). For example, a stent made of a Ni-Ti bidirectional shape memory alloy (containing approximately 51 atomic weight % Ni) spirally formed with a wall thickness of 0.04 mm and a width of 1 mm has an inner diameter of approximately 2 mm at body temperature. It was possible to shrink the inner diameter to about 1.4 mm at a temperature of 15° C. or lower.
このステント１０の内径、長さ等は目的とする留置部位
の器官に内部の大きさに応じて適宜選択される。要は拡
張時に留置されるべき血管等の管状器官の個所の内径と
一致させることができ、収縮時にはその個所まで挿入す
るのに十分な細さとすることができればよい。The inner diameter, length, etc. of this stent 10 are appropriately selected depending on the internal size of the organ at the intended indwelling site. The point is that it can match the inner diameter of the location of a tubular organ such as a blood vessel to be placed during expansion, and be thin enough to be inserted to that location during contraction.
ここで管状器官内腔の内径確保用器具の形状として上記
のらせん状の他に実質的の筒状のものがあるが、実質的
に筒状とは外面を連続させたときに筒状となるものをい
い、次に示す実施例に限らず、任意の形態を採用し得る
。例えば第２図（ａ）に示すように収縮時においては渦
巻き状をなし、拡張時には第２図（ｂ）の如く円筒をな
すようにしたもの、さらに二方向性形状記憶合金線条体
を編組した筒状体からなり、収縮時には第３図（ａ）の
如く網目が縮んだ構造の細長形状となり、拡張時には第
３図（ｂ）に示すように網目が拡がって内径が拡大する
ようなものであってもよい。さらに、第４図（ａ）の如
き収縮時に細いパイプ状をなし、拡張時に第４図（ｂ）
に示す如く太いパイプ状となるようなものであってもよ
い。In addition to the above-mentioned spiral shape, there are also substantially cylindrical shapes as the shape of the device for securing the inner diameter of the inner lumen of a tubular organ, but "substantially cylindrical" means that it becomes cylindrical when the outer surface is continuous. This is not limited to the embodiment shown below, and any form can be adopted. For example, as shown in Fig. 2(a), it forms a spiral when contracted, and when expanded, it forms a cylinder as shown in Fig. 2(b), and a bidirectional shape memory alloy filament is further braided. It consists of a cylindrical body, and when it contracts, it takes on an elongated shape with a structure in which the mesh has shrunk as shown in Figure 3 (a), and when it expands, the mesh expands and the inner diameter expands as shown in Figure 3 (b). It may be. Furthermore, it forms a thin pipe shape when contracted as shown in Figure 4(a), and as shown in Figure 4(b) when expanded.
It may also be shaped like a thick pipe as shown in the figure.
上述のステント１０を体内管状器官の目的とする留置位
置に導入する場合は例えば第５図に示す如きカテーテル
１２が用いられる。When the above-described stent 10 is introduced into a desired indwelling position in a tubular organ in the body, a catheter 12 as shown in FIG. 5 is used, for example.
このカテーテル１２は両端が開口したカテーテルチュー
ブ１４（例えばエチレン−酢酸ビニルコポリマーからな
る）と、このカテーテルチューブ１４の後端に、カテー
テルチューブのルーメンと連通ずるようにして設けられ
たハブ部１６（例えばポリカーボネ−１・からなる）と
からなっている。This catheter 12 includes a catheter tube 14 (for example, made of ethylene-vinyl acetate copolymer) that is open at both ends, and a hub portion 16 (for example, It consists of polycarbonate (1).
カテーテルチューブ１４の先端近傍の周面には多数の側
孔１８が穿設されていて、カテーテルチューブ１４内に
導入されたステント冷却液がこの側孔１Ｂを介して放射
状に排出されるようになっている。ハブ部１６は第６図
に拡大して示すように、直線状筒状部１６ａと、この直
線状筒状部１６ａの中間から分岐部１６ｂとからなって
いる。直線状筒状部１６ａはガイドワイヤの導入口とな
るものであって、そのため血液等の漏れを防止するため
の逆止弁２０（例えばシリコーンゴム等の柔軟素材から
なる）がその基端開口部近傍に調節されている。なお、
分岐部１６ｂは冷却液等の導入に用いられるものでポー
ト１６ｃを有する。A number of side holes 18 are bored in the circumferential surface near the tip of the catheter tube 14, so that the stent cooling liquid introduced into the catheter tube 14 is discharged radially through the side holes 1B. ing. As shown in an enlarged view in FIG. 6, the hub portion 16 includes a linear cylindrical portion 16a and a branch portion 16b extending from the middle of the linear cylindrical portion 16a. The straight cylindrical portion 16a serves as an introduction port for the guide wire, and therefore a check valve 20 (for example, made of a flexible material such as silicone rubber) for preventing leakage of blood, etc. is provided at its proximal opening. Adjusted to nearby. In addition,
The branch portion 16b is used for introducing cooling liquid and the like, and has a port 16c.
ステント１０を管状器官の留置位置へ導入するに際し、
まず、ステント１０をカテーテルチューブ１４の先端の
側孔１８部分に挿入する。ついで例えば水冷生理食塩水
をポート１６ｃから導入し、側孔１８から排出させるこ
とによりステント１０を１５〜２０°Ｃに冷却すると第
７図に示すようにステント１０がそのまま収縮してカテ
ーテルチューブ１４の側孔穿設部分１８に密着する。When introducing the stent 10 into the indwelling position of the tubular organ,
First, the stent 10 is inserted into the side hole 18 at the distal end of the catheter tube 14. Then, when the stent 10 is cooled to 15 to 20°C by introducing water-cooled saline through the port 16c and discharging it through the side hole 18, the stent 10 contracts as shown in FIG. It comes into close contact with the side hole bored portion 18.
次に側孔１８より氷冷生理食塩水を流出させたまま第８
図に示すように、管状器官２２内に予め導入されている
ガイドカテーテル２４中をカイトワイヤ２６を利用して
目的とする留置部位まで導入する。この留置部位に到達
したとき、水冷生理食塩水の導入を停止する。これによ
り、ステント１０が体温により次第に温められ、体温近
傍に温められると第９図に示す如く、ステント１０が拡
張し、管状器官２２内壁面に圧接し、保持される４した
がって、カテーテルチューブ１４の先端部をステント１
０から容易に引き抜くことができ、これによってステン
ト１０を管状器官２２の所定位置にそのまま留置させる
ことができる。Next, while the ice-cold saline is flowing out from the side hole 18,
As shown in the figure, a guide catheter 24 that has been previously introduced into a tubular organ 22 is introduced to a target indwelling site using a kite wire 26. When this indwelling site is reached, the introduction of water-cooled saline is stopped. As a result, the stent 10 is gradually warmed by the body temperature, and when the stent 10 is warmed to near the body temperature, as shown in FIG. Stent 1 at the tip
The stent 10 can be easily pulled out from the 0 position, so that the stent 10 can be left in a predetermined position in the tubular organ 22 as it is.
このステント１０を回収する場合は、カテーテルチュー
ブ１４の先端の側孔１８部分をステント１０内に挿入し
、水冷生理食塩水をポート１６ｃから導入し、側孔１８
から排出させることにより、ステント１０を収縮させ第
７図に示す如く側孔１８部分に密着させることができる
から、そのまま引き出すことにより回収することができ
る。ステント１０の留置位置を変更させたい場合も同様
の操作でおこなうことができる。When recovering the stent 10, insert the side hole 18 at the distal end of the catheter tube 14 into the stent 10, introduce water-cooled physiological saline through the port 16c, and
By discharging the stent from the stent, the stent 10 can be contracted and brought into close contact with the side hole 18 as shown in FIG. 7, so that it can be recovered by being pulled out as it is. If it is desired to change the indwelling position of the stent 10, the same operation can be performed.
なお、カテーテルチューブ１４先端に穿設される側孔１
８の数、範囲についてはステントの大きさ等を考慮して
任意に選択し得る。Note that the side hole 1 bored at the tip of the catheter tube 14
The number and range of 8 can be arbitrarily selected in consideration of the size of the stent, etc.
（発明の効果）以上詳述したように、本発明によれば、管状器−宮司ス
テントとして体温を基準とする温度変化により拡張、収
縮自在な二方向性記憶合金の円筒体を用いたから、留置
位置からの回収が可能となるとともに、拡張後における
留置位置の変更も容易となるなど顕著な効果を奏する。(Effects of the Invention) As described in detail above, according to the present invention, a cylindrical body made of a bidirectional memory alloy that can expand and contract freely due to temperature changes based on body temperature is used as the tubular device-Kyuji stent. It has remarkable effects such as being able to be retrieved from the same position and also making it easier to change the placement position after expansion.
さらに本発明に係わるステント操作用カテーテルによれ
ば先端周面に穿設した側孔を介してステントの収縮を自
由におこなうことができステントの導入１回収を極めて
簡単かつ容易におこなうことが可能となる。Furthermore, according to the catheter for stent manipulation according to the present invention, the stent can be freely contracted through the side hole drilled on the circumferential surface of the distal end, and the introduction and retrieval of the stent can be carried out extremely simply and easily. Become.
第１図（ａ）（ｂ）は本発明に係わる管状器官用ステン
トの側面図であって、（ａ）は収縮時、（ｂ）は拡張時
の状態を示し、第２図（ａ）（ｂ）ないし第４図（ａ）
（ｂ）は本発明の管状器官用ステントの斜視図であって
（ａ）は収縮時、（ｂ）は拡張時の状態を示し、第５図
は上記ステントの操作に用いられるカテーテルの側面図
、第６図は第５図のカテーテルのハブ部を拡大して示す
断面図、第７図は第４図のカテーテルに第１図のステン
トを装着した状態を示す側面図、第８図はおよび第９図
は第７図に示すカテーテルを用いて管状器官にステント
を留置させる場合の操作を説明する部分断面図である。図中、１０・・・ステント、１２・・・カテーテル、１
４・・・カテーテルチューブ、１６・・・ハブ部、１６
ａ・・・直線状筒状部、１６ｂ・・・分岐部、１８・・
・側孔、２０・・・逆止弁、２２・・・管状器官、２４
・・・ガイドカテーテル、２６・・・ガイドワイヤ。FIGS. 1(a) and 1(b) are side views of the stent for tubular organs according to the present invention, in which (a) shows the state when it is contracted, (b) shows the state when it is expanded, and FIGS. b) to Figure 4(a)
(b) is a perspective view of the stent for tubular organs of the present invention, in which (a) shows the state when it is contracted and (b) shows the state when it is expanded, and FIG. 5 is a side view of the catheter used for operating the above-mentioned stent. , FIG. 6 is an enlarged cross-sectional view of the hub portion of the catheter shown in FIG. 5, FIG. 7 is a side view showing the stent shown in FIG. 1 attached to the catheter shown in FIG. 4, and FIG. FIG. 9 is a partial cross-sectional view illustrating the operation of indwelling a stent in a tubular organ using the catheter shown in FIG. 7. In the figure, 10... stent, 12... catheter, 1
4... Catheter tube, 16... Hub part, 16
a... Straight cylindrical part, 16b... Branch part, 18...
- Side hole, 20... Check valve, 22... Tubular organ, 24
...Guide catheter, 26...Guide wire.
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| JP62070781AJPS63238872A (en) | 1987-03-25 | 1987-03-25 | Instrument for securing inner diameter of cavity of tubular organ and catheter equipped therewith |
| EP88902924AEP0411118B1 (en) | 1987-03-25 | 1988-03-25 | Instrument for securing inner diameter of inner cavity of tubular organ and catheter equipped with the instrument |
| AU14904/88AAU613027B2 (en) | 1987-03-25 | 1988-03-25 | Instrument for maintaining inner diameter of tubular organs and catheter provided with said instrument |
| KR1019880701459AKR910002422B1 (en) | 1987-03-25 | 1988-03-25 | Instrument for securing inner diameter of inner cavity of tubular organ and catheter equipped with the instrument |
| PCT/JP1988/000306WO1988007390A1 (en) | 1987-03-25 | 1988-03-25 | Instrument for securing inner diameter of inner cavity of tubular organ and catheter equipped with the instrument |
| DE3852892TDE3852892T2 (en) | 1987-03-25 | 1988-03-25 | INSTRUMENT FOR MAINTAINING THE INTERNAL DIAMETER OF A TUBE-SHAPED ORGAN AND CATHETER WITH THIS INSTRUMENT. |
| US07/607,767US5037427A (en) | 1987-03-25 | 1990-10-30 | Method of implanting a stent within a tubular organ of a living body and of removing same |
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| JP62070781AJPS63238872A (en) | 1987-03-25 | 1987-03-25 | Instrument for securing inner diameter of cavity of tubular organ and catheter equipped therewith |
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| JP5022091ADivisionJP2539955B2 (en) | 1991-02-25 | 1991-02-25 | A catheter equipped with a device for securing the inner diameter of the lumen of a tubular organ |
| Publication Number | Publication Date |
|---|---|
| JPS63238872Atrue JPS63238872A (en) | 1988-10-04 |
| JPH0351430B2 JPH0351430B2 (en) | 1991-08-06 |
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| JP62070781AGrantedJPS63238872A (en) | 1987-03-25 | 1987-03-25 | Instrument for securing inner diameter of cavity of tubular organ and catheter equipped therewith |
| Country | Link |
|---|---|
| US (1) | US5037427A (en) |
| EP (1) | EP0411118B1 (en) |
| JP (1) | JPS63238872A (en) |
| KR (1) | KR910002422B1 (en) |
| AU (1) | AU613027B2 (en) |
| DE (1) | DE3852892T2 (en) |
| WO (1) | WO1988007390A1 (en) |
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|---|---|---|---|---|
| JPH0286561U (en)* | 1988-12-26 | 1990-07-09 | ||
| JPH0435447U (en)* | 1990-07-19 | 1992-03-25 | ||
| WO2019188345A1 (en)* | 2018-03-30 | 2019-10-03 | 学校法人 久留米大学 | Stent |
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